Performance Comparison Between Comfilcon A and Senofilcon C Lenses

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CooperVision

Status

Completed

Conditions

Myopia

Treatments

Device: comfilcon A
Device: senofilcon C

Study type

Interventional

Funder types

Industry

Identifiers

NCT02920957
EX-MKTG-70

Details and patient eligibility

About

The aim of this study is to determine the clinical performance of comfilcon A in comparison to senofilcon C.

Full description

This is a prospective, multi-center, bilateral, double-masked, randomized, cross-over, daily wear, two month dispensing study comparing the clinical performance of comfilcon A and senofilcon C lenses after one month of wear.

Enrollment

88 patients

Sex

All

Ages

18 to 34 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

A person is eligible for inclusion in the study if he/she:

  • Is between 18 and 34 years of age (inclusive)
  • Has had a self-reported eye exam in the last two years
  • Is a spherical soft contact lens wearer
  • Has a contact lens spherical prescription between -1.00 to -6.00 (inclusive)
  • Has a spectacle cylinder no greater than 0.75D (Diopters) in each eye.
  • Can achieve best corrected spectacle distance visual acuity of 20/25 (0.10 logMAR) or better in each eye.
  • Can achieve a distance visual acuity of 20/30 (0.18 logMAR) or better in each eye with the study contact lenses.
  • Has clear corneas and no active ocular disease
  • Has read, understood and signed the information consent letter.
  • Has a contact lens prescription that fits within the available parameters of the study lenses.
  • Is willing and anticipated to be able to comply with the wear schedule (at least 6 days per week, 12 hours/day assuming there are no contraindications for doing so).
  • Is willing to comply with the visit schedule

Exclusion criteria

A person will be excluded from the study if he/she:

  • Has a history of not achieving comfortable CL (contact lens) wear (defined as 6 days per week; > 10 hours/day)
  • Presents with clinically significant anterior segment abnormalities
  • Presents with ocular or systemic disease or need of medications which might interfere with contact lens wear.

Presents with slit lamp findings that would contraindicate contact lens wear such as:

  • Pathological dry eye or associated findings
  • Significant pterygium, pinguecula, or corneal scars within the visual axis
  • Neovascularization > 0.75 mm in from of the limbus
  • Giant papillary conjunctivitis (GCP) worse than grade 1
  • Anterior uveitis or iritis (or history in past year)
  • Seborrheic eczema of eyelid region, Seborrheic conjunctivitis
  • History of corneal ulcers or fungal infections
  • Poor personal hygiene
  • Has a known history of corneal hypoesthesia (reduced corneal sensitivity)
  • Has aphakia, keratoconus or a highly irregular cornea.
  • Has presbyopia or has dependence on spectacles for near work over the contact lenses.
  • Has undergone corneal refractive surgery.
  • Is participating in any other type of eye related clinical or research study.
  • Is habitually using rewetting/ lubricating eye drops more than once per day
  • Is currently wearing daily disposable lenses

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

88 participants in 2 patient groups

comfilcon A
Active Comparator group
Description:
Participants are randomized to wear the comfilcon A lens for one month during the cross over study.
Treatment:
Device: comfilcon A
senofilcon C
Active Comparator group
Description:
Participants are randomized to wear the senofilcon C lens for one month during the cross over study.
Treatment:
Device: senofilcon C

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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